The US Food Safety Modernization Act (FSMA) What Must I do to Prepare?

The US Food Safety Modernization Act (FSMA) What Must I do to Prepare?
Japan External Trade Organization Tokyo – 16 February 2015 Kobe – 17 February 2015

OFW Law located in Washington, D.C., is a leader in implementation of the US Food Safety Modernization Act. OFW lawyers work closely with the US FDA to represent client interests and are helping food companies comply with thousands of pages of new FDA regulatory proposals and requirements. OFW Law is unique in that the firm includes a medical doctor, a pharmacist, a plant biologist, and a veterinarian. OFW’s Senior Policy Advisors have scientific expertise to assist clients with technical matters and OFW has close relations with third party accreditation and certification organizations.

OFW Law A Leader in FSMA Compliance
Bruce Silverglade, Principal OFW Law Washington, D.C. Tel: Fax: It is good to be back in Japan again and I am pleased to meet all of you.

FSMA – What Must I Do to Prepare?
Part I – Rules in Preventive Controls regulation requires food suppliers to create a “Food Safety Plan” Part II – Rules for Foreign Supplier Verification Program require food importers to verify their suppliers use risk-based preventive controls that provide the “same level of public health protection” as US requirements This presentation is for informational purposes only. It does not constitute legal advice. This presentation is based on the latest versions of the US FDA’s proposed regulations, which may change when FDA issues final regulations later this year.

FSMA – What Must I Do to Prepare?
Several important areas are beyond the scope of today's presentation: FDA regulation of safety standards for produce FDA regulation of sanitary transportation of food FDA regulation regarding intentional contamination of food Additional information available upon request FDA is issuing 50 new regulations, guidance documents, reports and studies required by FSMA. Not all can be covered in today’s presentation.

FSMA – Basic Change in US Law
FSMA makes fundamental changes in US food law – a preventive approach Places responsibility on food manufacturers and suppliers to have preventive controls to ensure food is safe Places responsibility on food importers to verify imported foods and foreign suppliers, instead of relying only on port-of-entry inspection

FSMA Compliance Dates Court-ordered deadlines for final rules:
Preventive Controls for Human/Animal Food – Aug. 30, 2015 Foreign Supplier Verification Programs – Oct. 31, 2015 Third Party Auditor Accreditation – Oct. 31, 2015 Produce Safety – Oct. 31, 2015 Sanitary Transportation of Food – March 31, 2016 Intentional Adulteration – May 31, 2016 “Small businesses” under US law have fewer than 500 employees Under FSMA, “very small businesses” have less than US$1 Million dollars in annual sales of food

FSMA Compliance Dates FDA promises to give all companies months to comply (from date of final regulation) Small and very small businesses have 1 and 2 extra years to comply Now is the time to prepare

► PRACTICAL CONSIDERATIONS
Start preparing now based on US FDA’s proposed regulations Necessary personnel and consultants needed to implement new requirements will be more difficult to find near the deadline for compliance Preparing now may provide competitive edge

Part I – FDA Preventive Controls Regulation for Human Foods

FSMA Preventive Controls – Who is covered?
Foreign and domestic facilities that are required to register with FDA Certain exemptions or modified requirements apply as follows . . .

Preventive Controls – Exemptions
Foods subject to US FDA seafood or juice regulations Low acid canned foods Certain fruits and vegetables subject to separate FSMA regulation for produce safety Meat/poultry subject to US Department of Agriculture rules Most alcoholic beverages Dietary supplements complying with FDA regulations Farms Farms - Farms that pack or hold another’s food (but still covered by FDA produce safety regulation) Farming activities of mixed-type facilities that also process food Certain low-risk on farm manufacturing/processing activities conducted by a small or very small businesses

Preventive Controls – Who is Covered by Modified Requirements?
Very Small Businesses – Documented proof that annual food sales are less than US$1 Million (adjusted for inflation). Such companies are exempt, but must still submit documentation demonstrating that the owner, operator or agent for the facility has identified potential hazards, is implementing preventive controls, and is monitoring the performance of those controls . . . BUT, documentation may consist of licenses, certificates, permits, certifications, or inspection reports that the facility is in compliance with relevant laws and regulations of foreign countries

Determine which of your facilities and products are covered by US FDA’s proposed preventive controls regulation Facilities solely engaged in the storage of packaged foods not exposed to the environment (shelf-stable products) are also exempt if they are not subject to time/temperature controls for food safety reasons.

What Should I Do If I Will be Covered by FDA Preventive Controls Regulation?
Assign responsibility to an employee or consultant who is a “Qualified Individual” (QI) to . . . Prepare a written food safety plan . . . For each type of food manufactured, processed, packed, or held by the facility Signed and dated by the owner, operator, or agent in charge of the facility

Appointment of a “QI” A “QI” is defined as “a person who has successfully competed training in the development and application of risk-based preventive controls at lease equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system

Determine whether any existing staff can serve as a “QI” - consider need for additional training In House QI allows for immediate reassessments of food safety plan Alternatively, determine if use of outside consultants is necessary Determine if records should be reviewed by outside party to verify compliance

Assemble a food safety team supervised by “QI” Team should include staff from operations, quality assurance, scheduling, maintenance, sanitation, and other departments

Your Food Safety Plan Must Include:
1. Hazard analysis 2. Preventive controls 3. Validation 4. Monitoring 5. Corrective actions 6. Verification 7. Record keeping

Food Safety Plan 1. What is a Hazard Analysis?
A Hazard Analysis must review known or reasonably foreseeable biological, chemical (including radiological), and physical hazards to determine if they are “significant” “Significant hazards” are reasonably foreseeable hazards for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would (based on the outcome of a risk analysis) establish controls to significantly minimize or prevent the hazard and (take steps) to manage those controls -- such as monitoring, corrective action, verification, and recordkeeping Chemical Hazards include undeclared allergens, pesticide residues, heavy metals, unapproved additives, and radiological hazards. Radiological Hazards include radio nuclides such as radium-226, radium-228, uranium-235, uranium-238, strontium-90, iodine-131, and cesium See,

Food Safety Plan What is a Hazard Analysis?
Includes economically motivated adulteration Should be risk-based considering the severity of the illness or injury that might occur, the probability of potential illness, and Includes environmental pathogens if the product is ready to eat and exposed to the facility environment and does not receive a treatment to control pathogens after packaging

Food Safety Plan The Hazard Analysis Should Consider:
The formulation of the food/raw ingredients The design of the equipment and facility Transportation practices Processing procedures Packing and labeling practices Storage and distribution The intended foreseeable use of the food (e.g. children) Employee hygiene Other relevant factors

A HAACP plan is not enough by itself Some preventive controls may not pertain to critical control points Even if you have a HAACP plan, it may need to be reviewed and possibly revised

Food Safety Plan 2. What are Preventive Controls? Processes
Select appropriate preventive controls, e.g. process controls, sanitation, allergen controls, temperature controls, and a recall plan Includes parameters for temperature, time/temperature, pH, or water activity, in situations such as heat treating, acidifying, dehydrating, refrigerating, chilling, brining, high pressure processing, ultraviolet light treatment, washing with antimicrobial agents

Food Safety Plan What are Preventive Controls? Allergens
Allergen controls – may include: physical barriers production sequencing equipment cleaning restricting movement of personnel and utensils within the facility minimizing formation of dust, aerosols, splashes, label procedures The US Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 requires that the label of a food that contains an ingredient that is or contains protein from a "major food allergen " declare the presence of the allergen. FALCPA identifies eight foods or food groups as the major food allergens. They are: milk, eggs, fish (e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat, Soybeans. More than 160 foods have been identified to cause food allergies in sensitive individuals. However, the eight major food allergens identified by FALCPA account for over 90 percent of all documented food allergies in the U.S. and represent the foods most likely to result in severe or life-threatening reactions.

Food Safety Plan What are Preventive Controls? Supplier Oversight
Supplier controls for raw materials and ingredients if they have a “significant hazard” Supplier controls may include: Periodic on-site audits of the supplier (performed by a “qualified auditor” but not necessarily a FDA accredited third-party auditor) Sampling/testing of the raw materials or ingredients Review of supplier’s food safety records Other reasonable methods This requirement only applies to manufacturers and processors, NOT to packers or holders.

Food Safety Plan What are Preventive Controls
Food Safety Plan What are Preventive Controls? Supplier Oversight (con’t) The choice of supplier verification activities is flexible, BUT • If there is a reasonable possibility that a significant hazard could result in serious adverse health consequences or death to humans or animals (“SAHCODHA”), facility must conduct onsite audit of supplier annually (unless manufacturer or processor documents that other verification activities are adequate) SAHCODHA includes a Class I recall, but FDA says the definition may cover additional circumstances not rising to the level of a Class I recall. Here is how FDA currently classifies Recalls: Class I Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens. Class II Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Class III Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.

Food Safety Plan What are Preventive Controls? Recall Plan
The preventive controls portion of a food safety plan must include a recall plan The recall plan must include steps to be taken (and the responsible employees) for notifying direct consignees of a recall, conducting effectiveness checks, and appropriate disposition of the recalled product

Food Safety Plan 3. Validate Preventive Controls
A QI (employee or consultant) must validate and document the preventive controls by collecting and evaluating information (contained in scientific publications, government documents, technical information from equipment manufacturers or the company’s own studies) determining that the Food Safety Plan will control all significant hazards (Validation is not required for sanitation controls, allergen controls, supplier controls, or the recall plan)

• Ensure that your preventive controls are effective • For example, does your time and temperature control eliminate biological concerns in your product (under the conditions that you produce the product)?

Food Safety Plan 4. Monitoring Procedures
The form of monitoring depends on the type of preventive control being utilized (e.g. visual observation, measurement of parameters, etc.) The frequency of monitoring must be sufficient to ensure that preventive controls are consistently performed Monitoring must be documented, including name and signature of employee, and date and time

You must monitor your preventive controls frequently enough to ensure all your product is acceptable Monitoring must be documented in “real time”

Food Safety Plan 5. Corrective Actions
Corrective actions must be taken whenever: A preventive control is not implemented or is ineffective A review of verification records finds appropriate decisions about corrective actions were not taken or that records are incomplete The manufacturer or processor learns that a supplier is not controlling significant hazards in a raw material or ingredient

Food Safety Plan Corrective Actions
Corrective actions must be taken whenever: Product testing reveals a pathogen or indicator organism in a Ready-to-Eat food Environmental monitoring reveals the presence of an environmental pathogen or indicator organism Appropriate corrective actions depend on the situation but generally include: - Identifying and correcting the problem - Evaluating all affected food for safety - Preventing all affected food from entering commerce until determining it is safe

Establishing corrective action procedures: Determine what corrective actions you will take if monitoring indicates preventive controls were not properly performed Address investigation of what caused the failure Ensure all affected product is controlled from the last acceptable check Determine needed preventive measures

Food Safety Plan Corrective Actions
If failure involves a sanitation or allergen control, only timely correction of the problem is required; detaining the affected food is not necessary

Food Safety Plan 6. Verification
A designated employee (other than the employee conducting the monitoring) must periodically verify the monitoring Verification of monitoring must be documented with employees name, signature, date and time A QI must verify and document with signature, date and time appropriateness of all corrective action decisions

Food Safety Plan Verification
The owner, operator, or agent must verify implementation and effectiveness of preventive controls You must verify that your equipment and procedures will produce the necessary parameters to allow all product to meet your control points Calibration of monitoring instruments on a regular basis Review, under the oversight of a QI, monitoring, corrective action records, calibration records, and if applicable, environmental monitoring records and/or product testing records

Verification must include environmental monitoring if the hazard analysis identifies an environmental pathogen as a significant hazard in a Ready-to-Eat food exposed to the facility environment and not receiving a lethal treatment after packaging FDA sought further public comments

An environmental pathogen (e.g., Salmonella, Listeria monocytogenes) is identified as a “significant hazard” and the product is exposed to the environment prior to packaging and does not receive an effective treatment after packaging

Examples: Rice is cooked and then cooled and packaged - as soon as the rice is below lethality temperature, it may become contaminated through post-lethality exposure prior to packaging Ingredients are assembled into a food box There is no lethality step in the process so all steps in the process prior to packaging provide post-lethality exposure concerns

Verification must include product testing if it is determined to be appropriate to verify the effectiveness of a preventive control Such requirements would be tied to risk and addressed through flexible written procedures that would address both test procedures and corrective action plans FDA sought further public comment For example, product testing may be appropriate when: Two environmental samples taken from food contact surfaces indicate a pathogen, or When monitoring determines that CGMP or SSOP were not followed, or To verify that CGMPs and SSOP are preventing contamination after a lethality treatment

Develop a product testing program: To provide verification that your preventive controls are effective in controlling the hazard If you are required to do environmental monitoring, and if you have a positive test result, you will need to commence intensive environmental monitoring and consider product testing as a verification measure

Environmental monitoring and product testing procedures must: Be scientifically valid Identify the test microorganism Identify potential sampling sites Identify the timing and frequency of sampling Identify the tests conducted and methods used Identify the laboratory conducting the testing Include corrective action procedures taken in the event of a positive test result

The Food Safety Plan must be reanalyzed at least every three years or sooner if: There is a significant change in the activities at the facility The manufacturer/processor becomes aware of new information about a potential hazard A preventive control is not implemented or is found to be ineffective Review of verification records finds records incomplete or appropriate corrective actions not taken

Reanalysis of Food Safety Plan must be overseen by a QI The revised plan must be signed and dated by the owner, operator, or agent in charge of the facility Reanalysis must be documented including the basis for concluding that no change is needed if that is the case

Food Safety Plan 7. Recordkeeping
Existing records may be used It is not necessary that all records be combined in one document, provided they can be made available to US FDA within 24 hours Electronic records meeting US FDA requirements are acceptable Record retention is generally 2 years The Food Safety Plan itself must be retained for 2 years after it was reanalyzed.

Food Safety Plan Recordkeeping
Food Safety Plan (including written hazard analysis, preventive controls, validation records, supplier control program, monitoring procedures, corrective action procedures, verification procedures and recall plan) Training records for QI and QA Supplier control, monitoring, corrective action, and verification records (including environmental monitoring and product testing if applicable)

Food Safety Plan Recordkeeping
Supplier control records must include: The supplier program (including selection of supplier verification activities and frequency Records of US FDA or other foreign inspections, if relied on Documentation that raw materials and ingredients are received only from approved suppliers Documentation of corrective actions taken in response to supplier non-conformance

Recordkeeping Must document everything! If you don’t record it, it didn’t happen If FDA inspects your facility, they will expect to see all of your records

Costs of exporting to US will increase But compliance will build confidence in food safety systems Compliance may provide competitive edge around the world

US FDA will eventually supply model Food Safety Plans Food Safety Preventive Controls Alliance to develop training courses and materials, See

Part II – FSMA Foreign Supplier Verification Program (FSVP)

FSVP – Determining Who is the “Importer”
FSMA requires food importers to have foreign supplier verification programs (FSVP), recognizing that traditional port of entry inspection is no longer sufficient The “importer” for legal purposes is the person in the US who has purchased the food for import in the US. If the food has not been sold to a person in the US at the time of US entry, the “importer” is the person in the US to whom the food has been consigned at the time of entry. If there is no US owner or consignee, the foreign owner or consignee of the food must designate a US agent or representative as the “importer” The “importer” for legal purposes is not necessarily the importer of record, such as a customs broker who pays import duties. Thus, many companies that do not normally think of themselves as importers will for legal purposes be “importers” subject to US FDA FSVP regulations.

FSVP – Identifying the Importer
Importers must obtain a “DUNS” number DUNS (Dun and Bradstreet Data Universal Numbering System) is an internationally recognized business entity listing system that assigns companies a unique identification number For each line entry of food, the name of the “importer” and the DUNS number must be provided electronically when filing entry with US Customs and Border Protection

FSVP – Who is NOT Covered?
Exemptions for juice, seafood, alcoholic beverages, dietary supplements in compliance with US laws for those products Foods imported for research, personal use, transshipped through US, or imported for export US FDA is considering an exemption for food imports where importer and foreign supplier are part of the same corporate family and subject to a single food safety system “Comparable” is more flexible standard to meet

►PRACTICAL CONSIDERATIONS
While comment period is officially over, FDA may still receive information about how this proposed exemption should apply Importers that are part of the same corporate family as the foreign supplier, and subject to a single food safety system, should consider providing information to the US FDA demonstrating why an exemption is appropriate 57

FSVP – Who is Subject to Modified Requirements?
Very small importers defined as less than US$ 1 Million in annual sales of food adjusted for inflation Food from very small foreign suppliers (less than US$1 Million annually) Food from suppliers in countries with food safety systems recognized by US FDA as “comparable” or “equivalent”

US FDA - Elements of FSVP
1. Appoint a “Qualified Individual” 2. Conduct a hazard analysis 3. Perform a risk evaluation 4. Conduct foreign supplier verification activities 5. Investigate complaints and take corrective action 6. Reassess your FSVP program 7. Recordkeeping

FSVP – “Qualified Individual”
A “qualified individual” (QI) must perform most FSVP activities including: Hazard analysis Risk evaluation Most verification activities Investigations and corrective actions Reassessments of the FSVP

FSVP – “QI” Defined A “QI” is defined as “a person who has the necessary education, training, and experience to perform the activities needed to meet the requirements” of the FSVP regulations. May be a foreign government employee Need NOT be an accredited 3rd party auditor

FSVP – Qualified Individual
QI can be employee of importer (or outside consultant) BUT - Must not have a financial interest in the foreign supplier - Payment to the QI cannot be based on the results of the activity

May have to hire additional staff to serve as “QI” May need to use consultants from outside your company 63

FSVP – Hazard Analysis Importer must, in writing, identify and evaluate (based on experience, illness data, scientific reports) “known or reasonably foreseeable” hazards to determine if any are “significant hazards” Importer must also consider hazards that may be intentionally introduced for unjust economic gain, especially if “economic adulteration” had occurred in the past and is reasonably foreseeable (examples – melamine, lead in dyes used to color spices)

FSVP Hazard Analysis Importer’s hazard evaluation must include an evaluation of environmental pathogens whenever a ready to eat food is exposed to the environment before packaging and the food does not receive a treatment to significantly minimize the pathogen

FSVP- Hazard Analysis Importer need NOT prepare a hazard analysis if foreign supplier has already done so as part of a food safety plan required by US FDA’s preventive controls regulation Importer must review and assess supplier’s hazard analysis

Doing business with foreign suppliers that have already prepared a hazard analysis meeting US FDA regulations may save the importer time and money! 67

FSVP Risk Evaluation Importer must perform “risk evaluation,” considering: The hazard analysis Which entity will control the hazards identified The foreign supplier’s food safety practices and procedures practices)

FSVP Risk Evaluation – Importer must perform “risk evaluation,” considering (cont.)
Applicable US FDA food safety regulations and the foreign supplier’s compliance history (including Warning Letters, Import Alerts, The foreign supplier’s food safety performance history (e.g., audit results, record of correcting problems) Any other appropriate factors (e.g., transportation)

FSVP Verification Activities
Importers are able to choose from: On-site audits of foreign supplier by “qualified auditor” (need not be FDA accredited auditor, but must have proper training and experience) Sampling/testing of imported food Review of supplier’s food safety records OR, Other appropriate verification activities Instead of on-site audit, importer may rely on inspection of supplier by US FDA or foreign safety authority recognized by the US FDA as “equivalent” or “comparable”

HOWEVER, If there is a reasonable probability that an imported food presents a “SAHCODHA” hazard, the importer must conduct annual on-site audits using “Qualified Auditor” UNLESS, importer documents that other verification activities (or less frequent on-site audits) provide adequate assurance that hazard is controlled

If your imported food involves a SAHCODHA hazard, start identifying “QAs” now Capacity of 3rd party auditing industry is expanding but limited 72

Obtain information on US FDA enforcement priorities to determine when to “play it safe” and utilize accredited 3rd party auditor even though not required by FDA regulations May provide an extra degree of protection from FDA scrutiny 73

Importer must retain documentation of each on site audit including Date of audit Procedures used for audit Conclusions and results of audit any corrective actions taken in response to significant deficiencies . . . but Importer need not maintain full audit report as a require record

FSVP Verification Activities Sampling and Testing
Sampling and testing may be performed by the importer or the supplier Detailed documentation must be retained

Hazard Analysis NOT required if: No significant hazards are identified Importer controls all significant hazards Importer's customer controls all significant hazards and the importer annually obtains written assure that its customer is following procedures to significantly minimize or prevent the hazards

If foreign supplier is a farm not subject to FDA’s produce safety regulation, importer must obtain written assurance every 2 years that the supplier produces food that complies with US law

3rd Party Auditors Can Conduct On-site Audits and Certify to Internationally Recognized Schemes

Global Food Safety Initiative
Private sector effort by to improve food safety US FDA has not yet stated its position regarding GFSI schemes but promises to rely on existing private standards FDA states: “The Federal Government recognizes that rigorous voluntary certification programs can provide assurance that products meet US requirements”

FSVP Verification Activities Use of “Accredited” Auditors
Although the FSVP does not require the use of “accredited” third-party auditors, FDA anticipates that importers may increasingly rely on audits by “accredited” third parties FDA may mandate use of “accredited” auditors for foods that FDA determines pose a safety risk, or in determining whether an importer is eligible for expedited entry of food into the US under the Voluntary Qualified Importers Program. FDA may set inspection priorities based on whether importer uses accredited 3rd party auditors FDA has published a separate proposed regulation setting forth rules for officially accrediting 3rd party auditors and their accreditation bodies

FSVP – PRACTICAL CONSIDERATIONS
Obtain advice and counsel on when to “Play it Safe” and use on-site auditing by accredited auditor or when to avail oneself of the discretion granted by US FDA for alternative supplier verification activities Stay “in tune” with US FDA enforcement priorities

FSVP – Investigations and Corrective Actions
Importer must promptly review any complaints from customers or consumers and investigate whether complaint potentially involves a food safety hazard Importer must promptly take corrective actions Corrective actions could include discontinuing use of foreign supplier or modification of importers’ FSVP

FSVP – Reassessment Procedures
Importers must assess the effectiveness of their FSVP at least every 3 years, and when importer becomes aware of new hazards associated with the imported food Reassessments of importers’ FSVP must be documented An updated risk evaluation is required

FSVP - Recordkeeping All records including supplier assurances, verification activities, corrective actions, and reassessments must be maintained in English! Records must be maintained for 2 years after they become irrelevant (because importer no longer imports the food, has changed suppliers, or changed its FSVP) Records must be maintained at place of business or immediately retrievable by computer for electronic transmission to FDA

FSVP- Very Small Importers and Food Imported from Very Small Foreign Suppliers
Need to maintain and follow a FSVP “QI” must be chosen “Importer” must be identified in customs entry by name and DUNS number Take appropriate corrective action Maintain required records

FSVP- Very Small Importers and Food Imported from Very Small Suppliers
BUT – Performance of a hazard analysis Conduct of verification activities Review of complaints to determine if they relate to adequacy of FSVP Reassessment of FSVP ARE NOT REQUIRED

US International Obligations to WTO
FSMA must be consistent with World Trade Organization agreement Same standards must be applied to imports and domestically produced foods Additional burdens on importers must be “scientifically justified” (SPS Agreement) and subject to WTO dispute resolution process

FSVP – PRACTICAL CONSIDERATIONS
Failure to comply can result in refusal of admission to US English language requirement creates burdens – may necessitate use of outside resources

Complicated, but Spring is on its Way

Contact Information Bruce Silverglade, Principal OFW Law, Washington, D.C.

The US Food Safety Modernization Act (FSMA) What Must I do to Prepare?

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